TRAMADOL/PARACETAMOL 37.5 MG / 325 MG TABLETS - patient leaflet, side effects, dosage

1. what this medicine is and what it is used for

This medicine has been prescribed for you for the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.

It contains tramadol hydrochloride which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for, and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take this medicine

Do not take this medicine:

• if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6).
• in cases of acute alcohol poisoning.
• if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions.
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs) or if you have taken MAOIs in the last 14 days before treatment with this medicine. MAOIs are used in the treatment ofdepression or Parkinson’s di­sease.
• if you suffer from a severe liver disorder.
• if you suffer from epilepsy that is not adequately controlled by your current medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine:

• if you are taking other medicines containing paracetamol or tramadol.
• if you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice.
• if you have kidney problems.
• if you have severe difficulties in breathing for example asthma or severe lung problems.
• if you have epilepsy or have already experienced fits or seizures.
• if you have recently suffered from a head injury, shock or severe headache associated with vomiting (being sick).
• if you are dependent on any medicine (for example morphine).
• if you are taking medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine.
• if you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol/Para­cetamol’).
• if you are going to have an anaesthetic (tell your doctor or dentist that you are taking this medicine).
• if you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• if you feel you need to take more of this medicine to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for, and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow orshallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Sleep-related breathing disorders

This medicine can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Talk to your doctor if you experience any of the following symptoms while taking Tramadol/Para­cetamol:

Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement.

If any of the above-mentioned points applied to you in the past or applies to you while you are taking this medicine, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.

Other medicines and Tramadol/Para­cetamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.

Do not take this medicine with MAOIs (see section “Do not take this medicine”).

This medicine is not recommended with the following medicines, as it may affect how well they work:

• Carbamazepine (a medicine used to treat epilepsy or some types of pain)
• Buprenorphine, nalbuphine or pentazocine (opioid-type pain killers)

The risk of side effects increases:

• if you are taking triptans (used for migraine) or selective serotonin re-uptake inhibitors (SSRIs, used for depression). Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea.
• if you are taking other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant), medicines used to lower blood pressure, or medicines to treat allergies. Check with your doctor if you feel drowsy or feel faint.
• concomitant use of Tramadol/Para­cetamol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Tramadol/Para­cetamol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take this medicine at the same time. Your doctor will tell you whether this medicine is suitable for you.
• if you are taking certain antidepressants. This medicine may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
• if you are taking warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4).

The effectiveness of this medicine may be altered if you also take the following medicines:

• Metoclopramide, domperidone and ondansetron (medicines used to treat nausea and vomiting/bein­g sick).
• Cholestyramine (medicine used to reduce cholesterol

in blood).

This medicine with food and alcohol

Do not drink alcohol while you are taking this medicine, as you may feel drowsy.

Children and adolescents

Use in children with breathing problems:

Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.

Pregnancy, breast-feeding and fertility

Do not take Tramadol/Para­cetamol if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Tramadol/Para­cetamol during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Tramadol/Para­cetamol tablets while you are breast-feeding as tramadol hydrochloride passes into breast milk and will affect your baby.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Driving and using machines

If you feel drowsy while taking this medicine, do not drive, use tools or use machinery.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Important information about the ingredients of Tramadol/Para­cetamol

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‚sodium-free‘.

3. how to take this medicine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your prescriber should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general, the lowest painrelieving dose should be taken.

Take this medicine for as short a time as possible and no longer than your doctor has told you.

Adults and adolescents over 12 years:

The recommended starting dose unless otherwise prescribed by your doctor is 2 tablets for adults and adolescents over 12 years. If required, further doses may be taken, as instructed by your doctor.

The shortest time between doses must be at least 6 hours.

Do not take more than 8 tablets per day.

Children under 12 years of age:

Not recommended.

Elderly patients

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or kidney disease (insufficiency)/di­alysis patients

Patients with severe liver and/or kidney insufficiency should not take this medicine. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration:

The tablets are for oral use.

Swallow the tablets with sufficient liquid.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you think the effect of this medicine is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.

If you take more of this medicine than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take this medicine

If you forget to take the tablets, pain is likely to return.

Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.

If you stop taking this medicine

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you experience any of these complaints after stopping this medicine, please contact your doctor. Other side effect information is listed in section 4.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them:

Some side effects could be serious. Contact your doctor immediately if any of the following occur:

• Rarely cases of skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment. Do not take the medicine again.
• Prolonged or unexpected bleeding, from the use of this medicine with medicines used to thin the blood (e.g. warfarin, phenprocoumon).

Additionally, if any of the following side effects become serious, contact your doctor or pharmacist.

Very common: may affect more than 1 in 10 people;

• nausea
• dizziness, drowsiness

Common: may affect up to 1 in 10 people;

• vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth
• itching, sweating (hyperhidrosis)
• headache, shaking
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits)

Uncommon: may affect up to 1 in 100 people;

• increase in pulse or blood pressure, heart rate or heart rhythm disorders
• tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle twitching
• depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), memory lapses
• difficulty breathing
• difficulty swallowing, blood in the stools
• skin reactions (for example rashes, hives)
• increase in liver enzyme values
• presence of albumin in urine, difficulties or pain on passing urine
• shivering, hot flushes, pain in the chest

Rare: may affect up to 1 in 1000 people;

• fits, uncoordinated movements, transient loss of consciousness (syncope)
• drug dependence
• delirium
• blurred vision, constriction of the pupil (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis)

Not known: (frequency cannot be estimated from the available data)

• decrease in the blood sugar level (hypoglycaemia)
• serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take this medicine’).
• dependence and addiction (see section „How do I know if I am addicted?“)
• hiccups

In addition, the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol:

• feeling faint when getting up from a lying or sitting position, slow heart rate, fainting
• changes in appetite
• muscle weakness, slower or weaker breathing
• mood changes, changes in activity, changes in perception
• worsening of existing asthma
• nose bleeds or bleeding gums, which may result from a low blood platelet count
• very rare cases of serious skin reactions have been reported with paracetamol
• rare cases of respiratory depression have been reported with tramadol

Drug withdrawal

When you stop taking this medicine, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking this medicine, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber.
• You feel you need to use more than the recommended dose.
• You are using the medicine for reasons other than prescribed.
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

5. how to store this medicine

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton (after EXP). The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What this medicine contains

The active substances are tramadol hydrochloride and paracetamol.

A tablet contains 37.5mg of tramadol hydrochloride and 325mg of paracetamol.

The other ingredients (excipients) are: Povidone (E1201), magnesium stearate (E152), colloidal anhydrous silicon, sodium starch glycolate (Type A) of potato and pregelatinised corn starch.

What this medicine looks like and contents of the pack

These tablets are oval and white for oral administration packed in cartons containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets. Not all pack sizes may be marketed. The tablets are scored and can be cut in half to make swallowing easier. Half doses should not be taken.

Marketing Authorisation Holder:

Aspire Pharma Ltd

Unit 4, Rotherbrook Court

Bedford Road

Petersfield

Hampshire

GU32 3QG

United Kingdom

Manufacturer:

Ferrer Internacional, S.A.

Joan Buscalla, 1–9,

Sant Cugat del Valles (Barcelona)

Spain

This leaflet was last revised in 07/2021

Aspire

PHARMA